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LAMOTRIGINE 25 MG TABLETS

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Risk of increased or severe seizures

PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 1. What Lamotrigine is and what it is used for 2. Before you take Lamotrigine 3. How to take Lamotrigine 4. Possible side effects 5. How to store Lamotrigine 6. Further information

The seizures in some types of epilepsy may occasionally become worse or happen more often while youre taking Lamotrigine. Some patients may experience severe seizures, which may cause serious health problems. If your seizures happen more often, or if you experience a severe seizure while youre taking Lamotrigine, see a doctor as soon as possible.

Taking other medicines

Tell your doctor or pharmacist if youre taking any other medicines, if youve taken any recently, or if you start taking new ones these include herbal medicines or other medicines you bought without a prescription. If you are taking certain medicines, your doctor may need to check the dose of Lamotrigine. These include: oxcarbazepine, felbamate, gabapentin, levetiracetam, pregabalin, topiramate or zonisamide, used to treat epilepsy lithium, used to treat mental health problems bupropion, used to treat mental health problems or to stop smoking. Tell your doctor if you are taking any of these. If you start or stop taking certain medicines whilst you are taking Lamotrigine, your doctor may need to check your dose of Lamotrigine. These include: atazanavir in combination with ritonavir lopinavir in combination with ritonavir Tell your doctor if you start or stop taking any of these. Some medicines interact with Lamotrigine or make it more likely that youll have side effects. These include: valproate, used to treat epilepsy and mental health problems carbamazepine, used to treat epilepsy and mental health problems phenytoin, primidone or phenobarbital, used to treat epilepsy olanzapine, used to treat mental health problems risperidone, used to treat mental health problems rifampicin, which is an antibiotic a combination of lopinavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection hormonal contraceptives, such as the Pill (see below). Tell your doctor if you are taking, or if you start or stop taking, any of these.

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WHAT LAMOTRIGINE IS AND WHAT IT IS USED FOR

Lamotrigine belongs to a group of medicines called anti-epileptics. It is used to treat epilepsy. Lamotrigine treats epilepsy by blocking the signals in the brain that trigger epileptic seizures (fits). For adults and children aged 13 years and over, Lamotrigine can be used on its own or with other medicines, to treat epilepsy. Lamotrigine can also be used with other medicines to treat the seizures that occur with a condition called Lennox-Gastaut syndrome. For children aged between 2 and 12 years, Lamotrigine can be used with other medicines, to treat those conditions. It can be used on its own to treat a type of epilepsy called typical absence seizures.

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BEFORE YOU TAKE LAMOTRIGINE

DO NOT take Lamotrigine:

if you are allergic (hypersensitive) to lamotrigine or any of the other ingredients of lamotrigine (listed in section 6). If this applies to you, tell your doctor, and dont take Lamotrigine.

Your doctor may recommend that you use a particular type of hormonal contraceptive, or another method of contraception, such as condoms, a cap or a coil. If Take special care with Lamotrigine you are using a hormonal contraceptive like the Pill, Your doctor needs to know before you take Lamotrigine: your doctor may take samples of your blood to check if you have problems with your kidneys the level of Lamotrigine. If you plan to start using a if you have ever developed a rash when youve taken hormonal contraceptive, talk to your doctor, who will lamotrigine or other medicines for epilepsy discuss suitable methods of contraception with you if you are already taking medicine that contains Lamotrigine can also affect the way hormonal lamotrigine. contraceptives work, although its unlikely to make If any of these applies to you, tell your doctor, who may them less effective. If you are using a hormonal decide to lower your dose, or that Lamotrigine is not contraceptive and you notice any changes in your suitable for you. menstrual pattern, such as breakthrough bleeding or Watch out for important symptoms spotting between periods, tell your doctor. These If you develop a rash or these skin symptoms, stop may be signs that Lamotrigine is affecting the way taking Lamotrigine, seek urgent advice from a doctor your contraceptive is working. and tell him that you are taking this medicine: Pregnancy and breast-feeding Potentially life-threatening skin rashes Talk to your doctor if youre pregnant, if you might be (Stevens-Johnson syndrome, toxic epidermal pregnant, or if youre planning to become pregnant. necrolysis) have been reported with the use of You should not stop treatment for your epilepsy Lamotrigine, appearing initially as reddish target-like while youre pregnant. However, there is an spots or circular patches often with central blisters increased risk of birth defects in babies whose on the trunk mothers took Lamotrigine during pregnancy. These Additional signs to look for include ulcers in the defects include cleft lip or cleft palate. Your doctor may mouth, throat, nose, genitals and conjunctivitis (red advise you to take extra folic acid if youre planning and swollen eyes) to become pregnant and while youre pregnant. These potentially life-threatening skin rashes are often Pregnancy may also alter the effectiveness of accompanied by flu-like symptoms. The rash may Lamotrigine, so your doctor may take samples of progress to widespread blistering or peeling of the skin your blood to check the level of Lamotrigine, and The highest risk for occurrence of serious skin may adjust your dose. reactions is within the first weeks of treatment Talk to your doctor if youre breast-feeding or If you have developed Stevens-Johnson syndrome planning to breast-feed. The active ingredient of or toxic epidermal necrolysis with the use of Lamotrigine passes into breast milk and may affect Lamotrigine, you must not be re-started on your baby. Your doctor will discuss the risks and Lamotrigine at any time benefits of breast-feeding while youre taking a high temperature (fever) Lamotrigine, and will check your baby from time to drowsiness. time if you decide to breast-feed. These symptoms are more likely to happen during the first few months of treatment with Lamotrigine, Driving and using machines especially if you start on too high a dose or if your dose Lamotrigine can cause dizziness and double vision. is increased too quickly, or if youre taking Lamotrigine Dont drive or operate machines unless you are sure with another medicine called valproate. Children are youre not affected. more likely to be affected than adults. If you have epilepsy, talk to your doctor about driving and using machines. The symptoms listed above can develop into more serious problems, such as organ failure or a very Important information about some of the ingredients severe skin condition, if they are not treated. If you of Lamotrigine notice any of these symptoms, see a doctor as soon as Lamotrigine tablets contain small amounts of a sugar possible. Your doctor may decide to carry out tests on called lactose. If you have intolerance to lactose or any your liver, kidneys or blood, and may tell you to stop other sugars, tell your doctor, and dont take Lamotrigine. taking Lamotrigine. Lamotrigine 100 mg and 200 mg tablets also contain E110 A small number of people being treated with anti-epileptics such as Lamotrigine have also had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

Hormonal contraceptives (such as the Pill) can affect the way Lamotrigine works

Thoughts of harming yourself or suicide

(sunset yellow FCF), which may cause allergic reactions.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Common side effects These may affect up to 1 in 10 people: aggression or irritability Always take Lamotrigine exactly as your doctor has rapid, uncontrollable eye movements (nystagmus) told you. You should check with your doctor or shaking or tremors pharmacist if you are not sure. difficulty in sleeping How much Lamotrigine to take It may take a while to find the best dose of Lamotrigine diarrhoea dry mouth for you. The dose you take will depend on: feeling tired your age pain in your back or joints, or elsewhere. whether you are taking Lamotrigine with other Rare side effects medicines whether you have problems with your kidneys or liver. These may affect up to 1 in 1,000 people: Your doctor will start you on a low dose, and gradually itchy eyes, with discharge and crusty eyelids (conjunctivitis). increase the dose over a few weeks until you reach a dose that works for you (called the effective dose). Never Very rare side effects These may affect up to 1 in 10,000 people: take more Lamotrigine than your doctor tells you to. hallucinations (seeing or hearing things that arent The usual effective dose of Lamotrigine for really there) adults and children aged over 12 years is between confusion or agitation 100 mg and 400 mg each day. feeling wobbly or unsteady when you move about For children aged 2 to 12 years, the effective dose uncontrollable body movements (tics), uncontrollable depends on their body weight - usually, its between muscle spasms affecting the eyes, head and torso 1 mg and 15 mg for each kilogram of the childs weight, (choreoathetosis), or other unusual body movements up to a maximum of 400 mg daily. such as jerking, shaking or stiffness How to take your dose of Lamotrigine in people who already have epilepsy, seizures Take your dose of Lamotrigine once or twice a day, as happening more often your doctor advises. You can take it with or without food. changes in liver function, which will show up in Your doctor may also advise you to start or stop taking blood tests, or liver failure other medicines, depending on what condition youre changes which may show up in blood tests - including being treated for and the way you respond to treatment. reduced numbers of red blood cells (anaemia), reduced Swallow your tablets whole. Dont break, chew or numbers of white blood cells (leucopoenia, crush them. neutropenia, agranulocytosis), reduced numbers of Always take the full dose that your doctor has platelets (thrombocytopenia), reduced numbers of all prescribed. Never take only part of a tablet. these types of cell (pancytopenia), and a disorder of the If you take more Lamotrigine than you should bone marrow called aplastic anaemia If anyone takes too much Lamotrigine, contact a doctor in people who already have Parkinsons disease, or pharmacist immediately. If possible, show them the worsening of the symptoms. Lamotrigine packet. Frequency not known Someone who has taken too much Lamotrigine may The frequency of these side effects cannot be estimated have any of these symptoms: from the currently available data: rapid, uncontrollable eye movements (nystagmus) swollen glands (lymphadenopathy) clumsiness and lack of co-ordination, affecting their aseptic meningitis. balance (ataxia) If you get side effects loss of consciousness or coma. If any of the side effects becomes severe or If you forget to take Lamotrigine troublesome, or if you notice any side effects not listed Dont take extra tablets or a double dose to make up in this leaflet, please tell your doctor or pharmacist. for a forgotten dose. If you have missed taking a dose of Lamotrigine, ask your doctor for advice on how to 5 HOW TO STORE LAMOTRIGINE start taking it again. Its important that you do this. Keep out of the reach and sight of children. Dont stop taking Lamotrigine without advice Take Lamotrigine for as long as your doctor recommends. Do not store above 30C. Store in the original blister pack to protect from moisture. Dont stop unless your doctor advises you to. Do not use Lamotrigine after the expiry date that is To stop taking Lamotrigine, it is important that your stated on the outer packaging. The expiry date refers to dose is reduced gradually, over about 2 weeks. If you the last day of that month. suddenly stop taking Lamotrigine, your epilepsy may If you have any unwanted Lamotrigine tablets, dont come back or get worse. dispose of them in your waste water or your household POSSIBLE SIDE EFFECTS rubbish. Take them back to your pharmacist, who will 4 dispose of them in a way that wont harm the Like all medicines, Lamotrigine can cause side effects, environment. but not everyone gets them.

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HOW TO TAKE LAMOTRIGINE

A small number of people taking Lamotrigine get an allergic reaction or potentially serious skin reaction, which may develop into more serious, and even life-threatening, problems if they are not treated. Symptoms of these reactions include: skin rashes or redness a sore mouth or eyes a high temperature (fever), flu-like symptoms or drowsiness swelling around your face, or swollen glands in your neck, armpit or groin unexpected bleeding or bruising, or your fingers turning blue a sore throat, or more infections (such as colds) than usual. Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported (see section 2). These are very serious but rare or very rare side effects. You may need urgent medical attention or hospitalisation. In many cases, your symptoms will be signs of less serious side effects. But you must be aware that they are potentially serious - so, if you notice any of these symptoms, see a doctor as soon as possible. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Lamotrigine. There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures. Check with your doctor or pharmacist if you are on long-term antiepileptic medication, have a history of osteoporosis, or take steroids. Very common side effects These may affect more than 1 in 10 people: headache feeling dizzy feeling sleepy or drowsy clumsiness and lack of co-ordination (ataxia) double vision or blurred vision feeling sick (nausea) or being sick (vomiting) skin rash.

Allergic reaction or potentially serious skin reaction: get a doctors help straight away.

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FURTHER INFORMATION

What Lamotrigine Tablets contain: The active ingredient is lamotrigine. The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised starch, povidone K-30, colloidal anhydrous silica, sodium starch glycolate (Type A) and magnesium stearate. In addition, the 100 mg and 200 mg tablets contain sunset yellow FCF (E110) and the 200 mg tablets contain indigo carmine (E132). What Lamotrigine Tablets look like and contents of the pack: Lamotrigine 25 mg tablets are white to off white, diamond shaped tablets, debossed with the number 93 on one side and scored between the two numbers, debossed 39 on the other side. Lamotrigine 50 mg tablets are white to off white, round shaped tablet, debossed with the number 50 on one side and debossed LT on the other side. Lamotrigine 100 mg tablets are peach, diamond shaped tablets, debossed with the number 93 on one side and scored between the two numbers, debossed 463 on the other side. Lamotrigine 200 mg tablets are blue, diamond shaped tablets, debossed with the number 93 on one side and scored between the two numbers, debossed 7248 on the other side. Lamotrigine packs are blister packs of transparent or white opaque PVC/PVDC-aluminium lidded with aluminium foil for 21, 21 calendar, 30, 42, 42 calendar, 56, 60, 90, or 100 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG. This leaflet was last revised: February 2012 PL00289/0496-0499
84100-Y 160 x 323

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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